BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIPIFLOW THERMAL PULSATION SYSTEM

    MDR report key: 6759764 · Received August 2, 2017

    Report

    Report Number
    3008169506-2017-00001
    Event Type
    Injury
    Date Received
    August 2, 2017
    Date of Event
    June 1, 2017
    Report Date
    August 1, 2017
    Manufacturer
    TEARSCIENCE, INC.
    Product Code
    ORZ
    PMA / PMN Number
    K161357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: OF THE MEIBOMIAN GLANDS AT THE SAME TREATMENT VISIT AS THE LIPIFLOW. A SUPERFICIAL CORNEAL ABRASION MAY OR MAY NOT RESULT IN PERMANENT DAMAGE OF THE CORNEA IF LEFT UNTREATED. HOWEVER, A PERMANENT INJURY IN THE ABSENCE OF MEDICAL MANAGEMENT CANNOT BE RULED OUT. THE LIPIFLOW CANNOT ALSO BE RULED OUT AS A POSSIBLE CONTRIBUTING FACTOR IN THE DEVELOPMENT OF THE ABRASION. AS SUCH, WE ELECTED TO REPORT THE EVENT. THE ACTIVATOR USED FOR THE TREATMENT (LFD-1000) WAS DISCARDED BY THE PRACTICE AFTER THE TREATMENT. HOWEVER, THERE WAS NO INDICATION THAT A PRE-TREATMENT INSPECTION OF THE ACTIVATOR REVEALED ANY DEFECTS IN THE ACTIVATOR OR PACKAGING, THE ACTIVATOR PASSED THE AUTOMATED SELF-TEST OF THE DEVICE AND THE DEVICE RECORDS INDICATE THAT THE TREATMENT OPERATED ACCORDING TO THE INTENDED SPECIFICATIONS. THIS CASE IS COMPLICATED BY SEVERAL FACTORS: THE PATIENT HAD A HISTORY SUGGESTIVE OF UNDIAGNOSED RECURRENT CORNEAL EROSION (SPORADIC EPISODES OF PAIN AND INFLAMMATION LASTING FOR A FEW HOURS ESPECIALLY IN THE EVENING). RCE IS A LISTED CONTRAINDICATION IN THE LABELING. THE PATIENT RECEIVED MANUAL EXPRESSION AND LIPIFLOW ON THE EVENT DAY, BOTH REQUIRING THE USE OF PROPARACAINE WHICH IS KNOWN TO IRRITATE THE CORNEAL EPITHELIUM. MANUAL EXPRESSION INVOLVES PHYSICAL MANIPULATION & PRESSURE APPLIED TO EYELID. THE TREATMENT PLAN, TO PLACE A CONTACT LENS AND ADDITIONAL PROPARACAINE OVER A CORNEA WITH 'TRACE SPK' IS UNUSUAL AND LIKELY ITSELF TO RESULT IN DISRUPTION OF THE CORNEAL EPITHELIUM. IT IS NOT KNOWN HOW MUCH THE PATIENT USED THE PROPARACAINE BETWEEN LEAVING AND RETURNING TO THE OFFICE. THE LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE), WHICH IS A COMPONENT OF THE LIPIFLOW SYSTEM, IS THE MEDICAL DEVICE SUSPECTED TO HAVE CONTRIBUTED TO THE PATIENT INJURY. OCULAR SURFACE IRRITATION OR INFLAMMATION (E.G. CORNEAL ABRASION, CONJUNCTIVAL EDEMA OR CONJUNCTIVAL INJECTION (HYPEREMIA)) AND OCULAR SYMPTOMS (E.G. BURNING, STINGING, TEARING, ITCHING, DISCHARGE, REDNESS, FOREIGN BODY SENSATION, VISUAL DISTURBANCE, SENSITIVITY TO LIGHT) ARE LISTED AS POTENTIAL ADVERSE EFFECTS THAT CAN OCCUR AS A RESULT OF THE PROCEDURE INVOLVING THE LIPIFLOW SYSTEM. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD A DIAGNOSIS OF MEIBOMIAN GLAND DYSFUNCTION, DRY EYE AND MODERATE TO SEVERE CHRONIC ALLERGIC CONJUNCTIVITIS. THE PATIENT HISTORY WAS SUSPICIOUS FOR UNDIAGNOSED RECURRENT CORNEAL EROSION. THE PATIENT WAS TREATED WITH THE LIPIFLOW FOLLOWED BY MANUAL EXPRESSION OF THE MEIBOMIAN GLANDS ON THE SAME DAY. AFTER BOTH TREATMENTS, THE PATIENT REPORTED FEELING 'WATERY AND SCRATCHY' IN THE LEFT EYE. THE MEDICAL RECORDS SHOWS THAT 'TRACE SPK' WAS OBSERVED ON THE LEFT EYE. A BANDAGE CONTACT LENS WAS PLACED ON THE LEFT EYE FOR THE 'TRACE SPK'. THE PATIENT WAS ALSO GIVEN PROPARACAINE DROPS TO USE AS NEEDED TWICE OR THREE TIMES A DAY ALONG WITH LOTEMAX (LOTEMAX WAS PRESCRIBED TO MANAGE THE PATIENT'S DRY EYE). THE PATIENT WAS INSTRUCTED TO RETURN TO THE OFFICE IN A FEW WEEKS FOR HER ROUTINE FOLLOW UP POST-LIPIFLOW AND MANUAL EXPRESSION. A FEW HOURS LATER THE PATIENT RETURNED TO THE OFFICE REPORTING PAIN. THE BANDAGE LENS WAS THEN REMOVED. MILD CORNEAL EDEMA WAS NOTED ON THE CHART. THE PATIENT WAS PRESCRIBED TOPICAL STEROID DROPS TO USE EVERY 2 HOURS AND SHE WAS REFERRED TO CORNEAL SPECIALIST THE NEXT DAY. THE CORNEAL SPECIALIST DIAGNOSED THE PATIENT WITH A SUPERFICIAL CORNEAL ABRASION AND TREATED HER PROPHYLACTICALLY WITH AN ANTIBIOTIC DROP, FOUR TIMES A DAY, FOR THREE DAYS ALONG WITH A TOPICAL STEROID DROP, TWICE A DAY, FOR 14 DAYS. AT THE FOLLOW UP EXAM AFTER 3 DAYS, THE PATIENT CORNEA WAS NOTABLY IMPROVED AND IT CONTINUED TO HEAL OVER THE NEXT 2 WEEKS. THREE WEEKS AFTER THE ADVERSE EVENT THE CORNEA WAS DOCUMENTED AS NORMAL AND THE BEST CORRECTED VISION IN THE LEFT EYE WAS DOCUMENTED AS 20/20. COMPARISON OF THE SUBJECTIVE REFRACTION FINDINGS FROM 2 WEEKS PRIOR TO THE LIPIFLOW AND MANUAL EXPRESSION AND AT BOTH THE OPTOMETRIST AND OPHTHALMOLOGISTS OFFICES AFTER THE TREATMENT DAY INDICATE THAT THE PATIENT EXPERIENCED A CHANGE IN HER PRESCRIPTION FROM HER CURRENT OLDER GLASSES. THE PRESCRIPTION CHANGE IN THE LEFT EYE WAS LARGER THAN THAT IN THE RIGHT EYE. THE REFRACTIVE DATA BETWEEN THE TWO OFFICES WERE NOT FULLY CONSISTENT. THERE ARE NO POST-TREATMENT KERATOMETRY DATA AVAILABLE. THE PATIENT HAS NOT RECEIVED OR REQUIRED ANY ADDITIONAL MEDICAL INTERVENTION SINCE (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542150 LIPIFLOW THERMAL PULSATION SYSTEM EYELID THERMAL PULSATION SYSTEM ORZ TEARSCIENCE, INC. LFD-1000

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention THE PATIENT RECEIVED MANUAL EXPRESSION (CONT.)